Medical device registration is an essential part of ensuring product safety, effectiveness, and quality. This article will introduce the whole process of medical device registration in detail, including pre-application preparation, registration test, clinical trial, establishment of system, application acceptance, approval of registration, issuance of registration certificate and follow-up supervision.

Abbott today announced financial results for the second quarter ended June 30, 2023.

On 5 July 2023, National Medical Products Administration announced the imported Class I medical device product in June 2023. A total of 145 product information, including 7 products in the IVD industry, were finally released.

On July 10, 2023, NMPA released information on the delivery of medical device approval certification documents.

On July 5th, the State Council Information Office held a series of press conferences covering the review and approval of medical devices, medical device regulation, innovative medical devices and other industry issues of concern.

Recently, the Tianjin Medical Products Administration issued the "Notice on the Demonstration and Promotion of the Unique Identification of Medical Devices".

In recent years, the State Council, the Development and Reform Commission and other departments have issued policies to support and regulate the biomedical industry.

According to the report of "The Developments and Trends of China's Medical Device Industry" released by Roland Berger, a world leading management consultancy, the Chinese medical device market exceeded 900 billion yuan in 2022. It is projected to exceed 2.2 trillion CNY (about 320 billion USD) by 2030, making China potentially the largest medical device market globally.

On May 8, Singlera Genomics announced that its self-developed PDACatch test, a novel DNA methylation-based liquid biopsy test for detecting pancreatic cancer in high-risk populations, has been granted Breakthrough Medical Device designation by FDA.

On April 14, DiaSorin announced that Mr Tony Chan is the President of DiaSorin China. He will also serve as the Chairman of the Board of Directors of DiaSorin China.